Table 1.
Comparison of study endpoints between both groups at the inclusion (week 0) and at both follow-ups (weeks 4 and 8).
| Week 0 | Week 4 | Week 8 | Comparison within Groups (Week 0–Week 8) | |||||
|---|---|---|---|---|---|---|---|---|
| Treatment Group N = 28 |
Control Group N = 28 |
Treatment Group N = 28 |
Control Group N = 28 |
Treatment Group N = 28 |
Control Group N = 28 |
Treatment Group N =28 |
Control Group N = 28 |
|
| PPIUS score (mean ± SD) | 3.8 ± 0.9 | 3.5 ± 0.7 | 3.4 ± 0.6 | 3.1 ± 0.9 | 2.9 ± 0.9 | 2.9 ± 0.8 | <0.001 * | 0.001 * |
| Weekly incontinence episodes × (mean ± SD) | 13.3 ± 16.1 | 6.7 ± 9.1 | 9.5 ± 11.3 | 4.1 ± 7.7 | 6.2 ± 8.9 | 3.8 ± 8.1 | <0.001 * | 0.008 * |
| Daily urinary frequency (mean, range) | 8.7 (6–13) | 9.0 (5–15) | 8.2 (5–13) | 8.2 (5–15) | 7.7 (5–13) | 7.6 (5–14) | 0.023 * | 0.001 * |
| Nocturia (mean, range) | 1.1 (0–3) | 1.4 (0–4) | 1 (0–3) | 0.9 (0–3) | 0.7 (0–3) | 0.9 (0–3) | 0.008 * | 0.002 * |
| Qmax [mL/s] (mean ± SD) | 24.3 ± 12.5 | 27.9 ± 13.7 | 23.7 ± 12.9 | 28.6 ± 11.4 | 22.9 ± 10.5 | 27.9 ± 10.2 | NS | NS |
| PVR [mL] (mean, range) | 9.3 (0–120) | 2.5 (0–30) | 13.7 (0–170) | 0.4 ± 1.9 (0–10) | 11.3 (0–110) | 0 (0) | NS | NS |
| I-QOL: total | 52.8 ± 27.2 | 58.6 ± 25.2 | 58.0 ± 25.8 | 63.0 ± 26.5 | 68.4 ± 23.4 | 71.1 ± 24,3 | <0.01 * | <0.01 * |
| - ALB | 50.9 ± 6.7 | 54.5 ± 23.6 | 56.4 ± 24.4 | 59.4 ± 24.5 | 67.7 ± 22.6 | 68.0 ± 24.0 | <0.01 * | <0.01 * |
| - PSI | 58.4 ± 29.1 | 66.1 ± 27.5 | 62.5 ± 28.5 | 69.8 ± 27.3 | 72.9 ± 25.9 | 76.6 ± 24.2 | <0.01 * | <0.01 * |
| - SE | 45.5 ± 29.8 | 52.0 ± 27.8 | 52.3 ± 27.3 | 56.6 ± 30.2 | 61.3 ± 24.4 | 66.3 ± 28.0 | <0.01 * | <0.01 * |
| UDI-6 | 53.8 ± 21.3 | 44.6 ± 24.1 | 47.2 ± 20.3 | 37.5 ± 26.5 | 35.5 ± 21.1 | 33.1 ± 20.2 | <0.01 * | <0.01 * |
| IIQ-7 | 38.9 ± 33.3 | 26.7 ± 30.3 | 28.6 ± 29.7 | 19.9 ± 21.6 | 22.4 ± 29.9 | 18.7 ± 26.4 | <0.01 * | <0.05 * |
Legend: PPIUS—patient perception of intensity of urgency scale, SD—Standard Deviation, Qmax—maximum urinary flow (mL/s), PVR—post-void residual urine volume (mL), I-QOL—Incontinence Quality of Life Questionnaire: ALB—avoidance and limiting behavior, PSI—psychosocial impacts, SE—social embarrassment; IIQ-7—Incontinence Impact Questionnaire—short form, SD—Standard Deviation, UDI-6—Urogenital Distress Inventory—short form, *—statistically significant difference, NS—no statistically significant difference, × N = 26 for both groups.